Amphastar Pharmaceuticals Inc. (NASDAQ: AMPH) shares are trading at $17.98 in premarket session, rising 3.33 percent. During Friday’s trading, shares of Amphastar stock dropped -0.97% to close at $17.40. The volume of AMPH stock was 0.14 million shares, which was lower than the 0.2 million average daily volume of the last 50 days. Because of FDA approval of Abbreviated New Drug Application (ANDA), AMPH stock is rising.
What approval AMPH has get?
As a biopharmaceutical company, Amphastar focuses primarily on developing, manufacturing, marketing, and selling extremely challenging generic, inhalation, and intranasal products and insulin API products. In hospital or urgent care clinical settings, AMPH finished products are mostly purchased and distributed through group purchasing organizations, as well as drug wholesalers.
Today, it was recently announced that Amphastar’s Abbreviated New Drug Application (“ANDA”) for Morphine Sulfate injection 1mg/mL in the 30mL Pump-Jet Prefilled Syringe System was approved by the FDA.
Generally, it is indicated for the management of severe pain, requiring patient-controlled analgesia, using the Alaris infusion device, and patients who are not receiving adequate treatment otherwise. The product has been marketed and sold for over 30 years through exclusion to the FDA’s “Prescription Drug Wrap-Up” program. For the year ending December 31, 2020, the AMPH only incurred net revenue of $2.3 million for its Morphine injections.
What does the CEO say?
Amphastar (AMPH) continues to manufacture high-quality injection products as the AMPH gets FDA approval for Morphine injection, said Amphastar’s CEO and President, Dr. Jack Zhang.